FRUDIA BLUEBERRY HYDRATING AIR FIT SUNSCREEN- octocrylene, homosalate, octisalate, avobenzone cream

FRUDIA Blueberry Hydrating Air Fit Sunscreen by

Drug Labeling and Warnings

FRUDIA Blueberry Hydrating Air Fit Sunscreen by is a Otc medication manufactured, distributed, or labeled by WELCOS CO.,LTD., Rebom Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

- Apply liberally 15 minutes before sun exposure. Reapply at least every two hours
- Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
- Ask a doctor to use for children under 6 months

ACTIVE INGREDIENT

Octocrylene 9.00%

Homosalate 7.30%

Octisalate 4.70%

Avobenzone 2.70%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

WARNINGS

For external use only

Do not use on damaged or broken skin

Stop using and ask a doctor if rash occurs

When using this product, keep out of eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT

Water, Butyloctyl Salicylate, Niacinamide, Dicaprylyl Carbonate, Dipropylene Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Poly C10-30 Alkyl Acrylate, Sorbitan Olivate, Polymethylsilsesquioxane, Vaccinium Angustifolium (Blueberry) Fruit Extract, Benzyl Glycol, Glyceryl Stearate SE, Panthenol, Carbomer, Arginine, Ganoderma Lucidum (Mushroom) Stem Extract, Tocopheryl Acetate, Glycerin, Glyceryl Glucoside, Disodium EDTA, Ethylhexylglycerin, Xanthan Gum, Hydroxypropyl Methylcellulose Stearoxy Ether, Adenosine, Caprylic/Capric Triglyceride, Propanediol, Sodium Hyaluronate Crosspolymer, Hydrogenated lecithin, Hydrolyzed Glycosaminoglycans, 1,2-Hexanediol, Sodium Hyaluronate, Tocopherol, Hydrolyzed Hyaluronic Acid, Phytosterols, Hyaluronic Acid, Fragrance

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRUDIA BLUEBERRY HYDRATING AIR FIT SUNSCREEN 
octocrylene, homosalate, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71017-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	73 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	47 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	27 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NIACINAMIDE (UNII: 25X51I8RD4)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
SORBITAN OLIVATE (UNII: MDL271E3GR)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)
ETHYLENE GLYCOL MONOBENZYL ETHER (UNII: 06S8147L47)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PANTHENOL (UNII: WV9CM0O67Z)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ARGININE (UNII: 94ZLA3W45F)
GANODERMA LUCIDUM STEM (UNII: U8PA41532G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL GLUCOSIDE (UNII: 3297VXM8Z6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
HYPROMELLOSE 2208 0.45% STEAROXY ETHER (UNII: MG58AH4FJ8)
ADENOSINE (UNII: K72T3FS567)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPANEDIOL (UNII: 5965N8W85T)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71017-001-02	1 in 1 CARTON	04/27/2024
1	NDC: 71017-001-01	50 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/27/2024

Labeler - WELCOS CO.,LTD. (689131584)

Registrant - WELCOS CO.,LTD. (689131584)

Establishment
Name	Address	ID/FEI	Business Operations
Rebom Co., Ltd.		695951708	manufacture(71017-001)